Fill Finish Sample Clauses

Fill Finish. Should Lilly (either by itself or by utilizing the services of a Third Person) choose to fill, package and supply Products to Xxxxx, Xxxxx may choose to process such formulations required for such Products itself, utilize services of a Third Person in any processing required for such Products or may use Generex for such processing (at a cost mutually agreed upon by Generex and Lilly).
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Fill Finish. CTI shall be responsible for the packaging, finishing and labeling activities (such as blistering and package inserts), to produce Licensed Product from Drug Product (“Fill/Finish”) in support of clinical studies; and Baxalta shall be responsible for Fill/Finish of Licensed Product for all commercial activity, subject to the execution of a Fill/Finish transition plan and technical transfer from CTI to Baxalta and/or Baxalta’s CMO. Any technology transfer expenses under this Section 8.5 are a Development expense.

Related to Fill Finish

  • Technical Specifications Each Bloom System is an integrated system comprised of a fuel cell stack assembly and associated balance of plant components that converts a fuel into electricity using electrochemical means that (i) has a Nameplate Capacity of at least 0.5 kilowatts of electricity using an electrochemical process and (ii) has an electricity-only generation efficiency greater than thirty percent (30%).

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Delivery Schedule The scheduled months of delivery of the Aircraft are listed in the attached Table 1. Exhibit B describes certain responsibilities for both Customer and Boeing in order to accomplish the delivery of the Aircraft.

  • Space Plans Within a commercially reasonable time period after the Execution Date, Tenant shall, at its sole expense (but subject to the Premises Construction Allowance), deliver to Landlord space plans prepared by an architect (“Architect”) chosen by Tenant and reasonably approved by Landlord in electronic Autocad format together with a full-size hard copy depicting all improvements and alterations desired by Tenant to be installed in or made to the Premises. Landlord shall notify Tenant whether it approves of such space plans within five (5) business days after receipt thereof. If Landlord disapproves of the space plans, Landlord shall notify Tenant thereof specifying in reasonable detail the reasons for such disapproval, in which case Tenant shall revise the space plans in accordance with Landlord’s objections and submit revised space plans in accordance with subparagraph (a) above to Landlord for its review and approval. Landlord shall notify Tenant in writing whether or not it approves of the resubmitted space plans within three (3) business days after its receipt thereof and, if Landlord disapproves, Landlord shall notify Tenant thereof specifying in reasonable detail the reasons for such disapproval. This process shall be repeated until the space plans have been finally approved by Landlord and Tenant. If Landlord fails to approve or disapprove of the space plans or the resubmitted space plans, as the case may be, within the applicable time period set forth above in this Section 2.(a), and any such failure is not cured by Landlord within three (3) business days after written notice from Tenant to Landlord of such failure, then the space plans as submitted, or as resubmitted, as the case may be, shall be deemed approved by Landlord. As used herein, “Space Plans” means the Preliminary Spaces Plans finally approved or deemed approved by Landlord as provided above. Material changes to the Space Plans shall require Landlord’s prior consent, which consent shall not be unreasonably withheld, conditioned or delayed. To the extent not attached hereto on the Execution Date, this Work Letter will be automatically amended to include as Annex 1 hereto the finally approved Space Plan.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Project Description The Project Description may be changed from time to time by, or with the consent of, the Company provided that any such change shall also be filed with the Issuer and provided further that no change in the Project Description shall materially change the function of the Project Facilities unless the Trustee shall have received (i) an Engineer's certificate that such changes will not impair the significance or character of the Project Facilities as Pollution Control Facilities and (ii) an Opinion of Bond Counsel or ruling of the Internal Revenue Service to the effect that such amendment will not adversely affect the exclusion of interest on the Bonds from gross income for federal income tax purposes.

  • Product Description The Products are described in the Product Unique Attachment(s). Products also include all FRUs, CSPs, Product code, and Product documentation.

  • State Specific Contract Form Observe the state of the Seller on the Contract, if the Seller lists an address in Alaska, Arkansas, Delaware, North Carolina, Virginia, Maryland, Montana, Connecticut, Vermont, Louisiana or Mississippi, confirm the form number on the Contract is on the List of Approved Contract Forms, for the corresponding state. Representation

  • Tenant Improvement Plans Any work proposed by Tenant at the Premises or Building (the “Tenant Improvements”) shall be subject to Landlord’s reasonable prior approval and shall be subject to the other terms and conditions of this Exhibit, which approval shall not be unreasonably withheld or delayed except for good cause shown. All architectural, engineering and other design fees shall be paid by Tenant, provided that, of the total Tenant Improvement Allowance, up to Five and No/100 Dollars (S5.00) per rentable square foot of the Premises of such fees may be subject to reimbursement under the Tenant Improvement Allowance. Tenant shall use its architect, engineers and other design professionals, all of whom shall comply with any applicable licensing or governmental requirements of the City of Santa Xxxxx and the State of California. Tenant shall cause its architect, who shall be subject to Landlord’s prior approval (“Tenant’s Architect”), which approval shall not be unreasonably withheld or delayed except for good cause shown, to prepare a draft space plan (the “Space Plan”) for the Tenant Improvements and shall submit the proposed Space Plan to Landlord for the latter’s approval (not to be unreasonably withheld or delayed) within twenty-one (21) days following mutual execution of the Lease. (If available upon mutual execution of this Lease, a mutually-approved preliminary space plan for the Tenant Improvements has been attached hereto as Exhibit C-1.) Landlord shall deliver to Tenant any written objections, questions or comments of Landlord with regard to the Space Plan, and Tenant shall cause the Space Plan to be revised to address such written comments and shall resubmit said Space Plan to Landlord for approval within five (5) business days thereafter. Such process shall continue until Landlord has approved the Space Plan. Tenant’s Architect shall then prepare working drawings and specifications for the Tenant Improvements, including architectural, structural, plumbing, mechanical, electrical, and fire protection drawings as required, suitable for permit application (the “Working Drawings”) and shall submit the proposed Working Drawings to Landlord for the latter’s approval within sixty (60) days following Landlord’s approval of the final Space Plan. The Space Plan and Working Drawings shall be subject to Landlord’s approval, which Landlord agrees shall not be unreasonably withheld or delayed. Landlord shall not be deemed to have acted unreasonably if it withholds its approval thereof because, in Landlord’s reasonable opinion as supported by statement or reports from licensed engineers, the work, as described in any such item: (i) will adversely affect Building systems, the structure of the Building or the safety of the Building and/or their occupants; (ii) will materially impair Landlord’s ability to furnish services to Tenant or other tenants at the Project; (iii) would materially increase the cost of operating the Building; (iv) would violate any governmental laws, rules or ordinances (or interpretations thereof); (v) contains or uses hazardous or toxic materials or substances not permitted under Applicable Laws; (vi) would affect the external appearance of the Building; (vii) would materially and adversely affect another tenant’s premises at the Project: or (viii) is prohibited by any mortgage, trust deed or other instrument encumbering the Building or Project. Landlord shall deliver to Tenant any written objections, questions or comments of Landlord with regard to the Working Drawings, and Tenant shall cause the Working Drawings to be revised to address such written comments and shall resubmit said Working Drawings to Landlord for approval within ten (10) business days thereafter. Such process shall continue until Landlord has approved the Working Drawings. Landlord’s approval of the Space Plan and/or the Working Drawings shall not be deemed any representation or warranty that the same comply with applicable codes.

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